MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.(b)(6).

Event Description

The customer reported the mx400 has intermittent issue.Display hangs while moved.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

The field service engineer (fse) went onsite and checked and verified that the device would hang intermittently while on the move.The fse determined that the main board was faulty on the display connection, so it caused intermittent unit hangs.The fse recommended to replace the main board.The engineer provided their analysis findings; however, we are unable to confirm the final disposition of the device, because the customer did not call back for further support.Based on the information available and the testing conducted, the cause of the reported problem was the main board.The reported problem was confirmed.

Event Description

The customer reported the intellivue mx400 patient monitor would intermittently hang when move.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Type of Device: INTELLIVUE MX400 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17787019
• MDR Text Key: 323894742
• Report Number: 9610816-2023-00470
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: 00884838038752
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866060
• Device Catalogue Number: 866060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1